|Publication number||US8012078 B2|
|Application number||US 11/709,652|
|Publication date||Sep 6, 2011|
|Filing date||Feb 22, 2007|
|Priority date||Sep 24, 2001|
|Also published as||CA2460174A1, CN1556719A, EP1429649A2, EP1429649A4, US7182725, US20030153802, US20070173812, US20110196186, WO2003026480A2, WO2003026480A3|
|Publication number||11709652, 709652, US 8012078 B2, US 8012078B2, US-B2-8012078, US8012078 B2, US8012078B2|
|Inventors||Raoul Bonan, Charles E. Larsen, Roelof Trip, Douglas B. Schumer, Jack C. Griffis, III, Andrew L. Lerohl|
|Original Assignee||Best Vascular|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (64), Non-Patent Citations (4), Classifications (16), Legal Events (3)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/324,299, filed Sep. 24, 2001, and incorporates by reference aforesaid application.
The present invention generally relates to the treatment of cardiac arrhythmias (atrial and ventricular) such as, but not limited to, atrial fibrillation and/or to the treatment of vascular restenosis after the use of other ablation techniques. More specifically, the present invention is directed to unique apparatus and/or methods employing ionizing radiation for ablating cardiac issue to treat cardiac arrhythmias.
The coordinated contraction of the various chambers of the human heart during a normal heartbeat is controlled by a relatively complex electrical system. The electrical signal that initiates each heartbeat begins at an area in the right atrium commonly called the “sinus node” or the “sinoatrial node.” The electrical signal rapidly spreads across the right and left atria. The electrical signal is conducted to the ventricles of the heart through a connection called the atrioventricular node (AV node). From the atrioventricular node, the electrical signal passes along a bundle of special cells in the heart, known as a Bundle of His, which spreads the electrical signal rapidly through the ventricles.
The regular and normal rhythm of the heart is usually called the sinus rhythm. When the proper sequence or path of electrical signals is delayed or interrupted, an arrhythmia may develop. Anatomically, arrhythmias may be grouped according to the location where the disturbance in the electrical system arises, such as “ventricular” arrhythmias that arise in ventricles, and “atrial” or “supraventricular” arrhythmias that arise in heart tissue located above the ventricles.
In addition, arrhythmias are identified based on whether the electrical system malfunction is in the conduction of the electrical signal or impulse, or in the generation of the electrical signal or impulse. An impulse conduction failure will sometimes involve a phenomenon known as “re-entry,” which occurs when the electrical signal travels in closed pathway or loop. This can occur, for example, when the AV node fails to conduct the signal properly from the atria to the ventricles, and the resultant AV nodal re-entry can cause very rapid beating of atria, sometimes called “supraventricular tachycardia.” “Tachycardia” simply refers to a faster than normal heart rhythm.
One well known type of cardiac arrhythmia is known as atrial fibrillation. Atrial fibrillation, or AF, occurs when rapidly circulating abnormal electrical impulses stimulate the atrium to beat very fast—up to several hundred beats per minute or more. The rapid electrical pulses may also be passed by the AV node to the ventricles, causing fast and irregular ventricular contractions.
An increasingly well accepted procedure for treating cardiac arrhythmias in general, and atrial fibrillation in particular, is referred to as ablation. After the source of the disruption in the electrical system is determined, the tissue of the heart is ablated to eliminate the source of the aberrant impulses or to form a lesion or scar which interrupts and isolates the source of the aberrant electrical signal. It has been proposed to carry out such ablation by cryogenic probes or electrical radiofrequency (rf) energy electrodes. U.S. Pat. No. 6,161,543, for example, discloses various shapes of cryogenic probes that may be used to carry out the so-called MAZE procedure in which a series of lesions are formed strategically around the pulmonary trunk and elsewhere in the heart muscle to create an electrical maze that delays the aberrant electrical signals and prevents fibrillation of the atrium. U.S. Pat. No. 6,161,543 is incorporated by reference into this application, in its entirety.
Although cryosurgical probes and rf energy electrodes are used with increasing frequency in treating cardiac arrhythmias via heart tissue ablation, there continues to be a desire for additional apparatus and methods in the armamentarium of cardiologist for the detection and treatment of cardiac arrhythmia. For example, forming continuous linear lesions without breaks or disruptions and of uniform depth along the entire lesion lengths are challenging at the very least for cardiologists and electrophysiologists. Additionally, determination of the site of electrical malfunction requires what is known as electrophysiology mapping—which is commonly carried out as a separate procedure. It would be advantageous if the mapping and ablation could be carried out with the same instrument in the same procedure.
There also continues to be a desire for additional apparatus and methods in the armamentarium of cardiologist for the treatment or prevention of conditions resulting from the treatment of cardiac arrhythmias. For example, it is known that ablation around the pulmonary vein will sometimes result in stenosis, or closure, of the vein. Despite efforts to open the pulmonary vein and to place a stent in the vein to hold it open, patients suffering from repeated restenosis of the pulmonary vein often have a doubtful prognosis. Accordingly, there is a need to provide method and apparatus for alleviating stenosis of the pulmonary and other veins, that may be caused by other ablation treatment of cardiac arrhythmias.
The present invention is directed, in one aspect, to methods and apparatus which employ ionizing radiation for ablating heart tissue to treat cardiac arrhythmias, including without limitation both impulse conduction and impulse generation arrhythmias, and both ventricular and atrial arrhythmias. In accordance with this aspect of the present invention, an ionizing radiation source, such as a beta, gamma, x-ray or other source, is brought into immediate proximity or contact with the heart tissues to be ablated. The radiation source is of a selected activity and the contact time with the tissue (which may vary with the target tissue and can be determined without undue experimentation) is sufficient to ablate the tissue and obtain the desired treatment of the arrhythmia.
This method may be achieved by a radioactive tipped catheter or wire or, more preferably, by employing a catheter such as the Beta-Cath™ catheter (presently sold by Novoste Corporation of Norcross, Ga.) in which a train of radioactive sources are hydraulically advanced into the distal end of the catheter after it is properly positioned against the wall of the heart where the ablation is desired. The radioactive train may be of any desired length, which may be varied, to create the desired linear lesions in the heart muscle. Such a catheter lends itself particularly well to endocardial placement through the vascular system of the patient, and to the MAZE type procedure in particular. However, the present invention is not limited to an endocardial approach and includes the possible placement of the radioactive source(s) epicardially, on the outside surface of the heart, either by an open chest procedure or by a minimally invasive procedure through a trocar, endoscope or the like.
In accordance with a more specific aspect of the present invention, and particularly for endocardial applications, the delivery catheter may have means on the distal end to allow for steering and/or for active fixation of the distal end against the inner surface of the heart wall at the desired location. The fixation means may comprise, for example, a basket or nest arrangement or a loop located on the distal end of the catheter that may be deployed from a retracted position during catheter placement to a deployed position in which the basket or nest or loop rests against an opposing surface of the heart chamber to hold the catheter at the desired location for the ablation. In other words, upon deployment, the basket or nest or loop would engage against an opposing wall surface and hold or push the catheter against the inside surface of the wall or in close proximity to it at the location to be ablated. The basket or nest or loop could be deployed, for example, by releasing a pull wire attached to a pretensioned basket or nest or loop. Alternatively, the basket or nest or loop could be located in the retracted position within a sleeve or sheath that, upon axial movement, allows deployment of the basket or nest or loop.
Alternatively, the distal end of the catheter may be preformed into a desired shape, such as a classic pigtail shape or a spiral shape or loop or lasso. For example, a predetermined shape may be formed on the end of the catheter by thermally presetting or by other known techniques. Alternatively, or additionally, a guide wire could be used to assist in retaining the distal end of the catheter in the desired shape or to form an otherwise straight and flexible catheter into the desired shape.
Any of the above embodiments of the preferred catheter has the advantage of allowing the catheter to be accurately placed within the heart, and inside the atrium and the pulmonary veins in particular, before the radioactive sources are introduced into the catheter thus minimizing unnecessary radiation exposure; to create linear lines of ablation at the desired locations of selected and variable length; to permit repositioning of the catheter while the radioactive sources are outside the patient's body when treating multiple sites; and to reduce the treatment time as compared to other procedures and avoid the need to perform the highly invasive open chest MAZE surgical procedure.
In accordance with a further aspect of the present invention, ionizing radiation may be employed to modify, without complete ablation, the conduction characteristics of the AV node to treat or prevent arrhythmias arising from AV node malfunction. Prior procedures have typically required complete ablation of the AV node to treat certain arrhythmias. One drawback with this approach is that it requires permanent implantation of a pacemaker to replace the function of the AV node. Apparatus and methods which permit modification of the conduction characteristics of the AV node without complete ablation would be a particular advance over prior methods and apparatus for treating arrhythmias related to AV node malfunction, such as re-entrant tachycardias.
In connection with a further aspect of the present invention a catheter embodying the features of the present invention may be used in combination with an instrument for assessing the electrophysiology of the heart. For example the present invention may be combined with a device, such as disclosed in U.S. Pat. No. 5,529,067, which employs the Peltier effect for cooling or warming heart tissue to determine the location of aberrant electrical signals or otherwise mapping the electrophysiology of the heart.
Additional aspects and features of the present invention may be found in the following description of the attached drawings, of which:
The human heart has four chambers, the right atrium 4 and right ventricle 6, which are connected together by a valve 8, and the left atrium 10, and left ventricle 12 which are also connected by a valve 14. The function of the atria is to receive blood from the veins and to store it for each heartbeat. Blood returning from the major organs of the body and muscles, which is depleted of oxygen, is delivered first to the right atrium. This blood is then delivered to the right ventricle, which pumps the oxygen depleted blood to the lungs where carbon dioxide is expelled and oxygen replenished. Re-oxygenated blood flows from the lungs, through right and left pairs of pulmonary veins, to the left atrium. From the left atrium, the re-oxygenated blood flows into the left ventricle which operates as the main pumping chamber for pumping oxygen-replenished blood to the muscles and organs of the body.
As discussed briefly earlier, a normal heartbeat starts in the right atrium 4, when both of the atria 4 and 6 contract to force blood past the one-way valves 8 and 14 between the left and right atria and their respective ventricles. Quickly after contraction of the atria, the ventricles begin to contract. The one-way valves between the atria and the ventricles prevent the blood from flowing backwards. The blood expelled from each ventricle passes through another one-way valve, which closes after contraction of the ventricle.
This coordinated and sequential contraction of various chambers of the heart is controlled by the heart's electrical system. Referring to
In accordance with present invention, delivery of the radioactive sources, apparatus and systems marketed by Novoste Corporation of Norcross, Ga. may be employed in the delivery of the radioactive sources. The Novoste™ system which is generally shown in
At the proximal end of the catheter, which is located outside the patient in a percutaneous procedure such as described above, a transporting and/or loading device 30 is provided for loading a radioactive source or train of sources, such as pellets or capsules (also called “seeds”) comprising or containing radioactive material, into the send lumen 26 of the catheter 20. Additional seeds may also be loaded such that the total length of the combined seeds corresponds to at least the length of the lesion to be ablated.
After the radioactive source or source train is loaded, pressurized blood-compatible liquid, such as sterile saline solution or sterile water, is introduced via liquid source 32 through a port 34 in the proximal end of the send lumen 26 behind the source(s). Flow of liquid through the lumen pushes the source(s) along the send lumen to the distal end portion, which is located at the site to be treated. The liquid which provides the motive force for moving the sources may be allowed to exit from the distal end of the catheter, but is preferably returned in a parallel return lumen provided in the catheter that communicates at the distal end of the catheter with the send lumen.
After the radioactive source or sources train is located at the desired site, it is allowed to remain for a time sufficient to ablate the tissue. It is apparent that the source train, although made up of separate radioactive seeds or pellets, provides an elongated and essentially continuous radiation source that may be used to form lines of ablated tissue through the heart, atrium, wall. The radioactive sources are preferably beta-emitting, although gamma-emitting, x-ray or other sources could be used, and the residence time period will be relatively short, on the order of minutes as discussed in more detail below. The activity of the radiation sources and the residence time may vary and be selected depending on the thickness of the heart tissue to be ablated. The precise activity and residence time is presently not fully known, but may be ascertained with routine and well know testing techniques that do not require undue experimentation.
After the treatment is complete, the catheter may be removed or shifted to a different treatment position. The radioactive sources are preferably returned to the leading device while the catheter is removed or shifted in order to avoid undue radiation exposure to the patient. To retrieve the radioactive sources, liquid may be forced through the send lumen in a reverse direction to return the treating element to the proximal end and into the loading device, if desired, before removal of the catheter. The reverse flow of fluid may be achieved by forcing liquid under positive pressure through the return lumen in a reverse direction, which forms a closed loop with the send lumen, forcing the sources in a reverse direction to the loading device 30.
The source train is made up of a plurality of radioactive small sources or seeds 42 pre-loaded into a source train lumen 43 in radiation-shielding cartridge 44. The loading device 30 includes a receiving recess or station 46 into which the cartridge 44 may be inserted. Alignment of source train lumen 43 with the send lumen 38 allows the seeds to be ejected and transmitted along the send lumen to the distal end of the catheter. For example, a liquid-filled syringe may be attached to the send lumen 38 of the loading device to force the source train seeds to the distal end of the catheter. To remove the sources after ablation is complete, or to shift the catheter position, a syringe or other pressure source may be attached to the return lumen 40 of the device to force liquid flow in the reverse direction, returning the source train to the loading device and into the cartridge 44. A switching arrangement could be arranged in the loading device so that a single syringe could be used, and the flow switched between the send and return lumen, as required.
The length of the source train 54 may be selected as needed to ablate a lesion of the desired length. A single radioactive element or point source may be sufficient to ablate or treat localized areas, such as modifying the properties of the AV node. However, a source train of selected length is preferred for forming linear lesions or scar tissue such as those that may be used in the MAZE procedure. Because it may be required to vary the length of the source train, the loading device may be designed to store a plurality of source trains of different lengths, so that the user can retrieve the source train of the length needed for a particular line of ablation, or to store radioactive seeds in a way that allows the user to create source trains of the different desired lengths.
As seen in
It is contemplated that these alternative shapes would be used with a radiation source delivery catheter having a sufficiently flexible distal end to conform to the shape of the guide wire. The guide wires of
Alternatively, the catheter itself could have a pre-shaped distal end, such as curved, pig-tail or spiral to engage the heart wall in the desired position for ablation. This shape could be set into the end of the catheter using known techniques such as heat setting, molding or the like. With this type of catheter, the guide wire would tend to straighten the catheter during insertion, and withdrawal of the guide wire would allow the catheter to resume its preset shape. After properly positioned against the wall of the heart at the location to be ablated, the radioactive sources would be inserted into the end of the catheter for the ablation treatment.
The catheter (see
Further, the catheter may include a cooling surface 63 on the distal end portion for cooling selected cardiac tissue, for example, to identify the desired site for ablation or other radiation treatment. This cooling surface could be based on the Peltier effect, as disclosed for example. in the previously mentioned U.S. Pat. No. 5,529,067, and also connected via one or more conductors extending through the catheter. More specifically, systematic cooling of selected heart tissue and observation of the effect of cooling on the electrophysiology may be used to identify the location of tissue to be ablated or treated, and once identified, the treatment can be immediately carried out by advancing the radiation source through the catheter and to the site without further movement of the catheter required. This has the potential benefit of better assuring that treatment is being carried out at the desired location.
It is preferable that the steering wires not be located between the radiation source and the line of tissue to be ablated, because this may result in attenuation of the radiation or a disturbance in the radiation dose distribution. In an alternative embodiment, the steering wire lumens may be positioned differently in relation to the radiation source and fluid delivery lumens, as shown in
The spokes 76 may be of thin stainless steel, plastic or other suitable material and. are pre-arranged, as by pre-stressing, to expand away from the catheter when the tip end is bent, as shown in
In accordance with another alternative of the present invention, the spokes themselves could be radioactive, such as by coating with a radioactive material, having a radioactive material imbedded in them or other technique. In this arrangement, the spokes need not be parallel to one another, but may be arranged in such a pattern as desired to form multiple oblique lines of ablation within the heart upon deployment of the basket in contact with the heart wall.
In addition to stainless steel or plastic, the spokes in this embodiment may be a shape memory alloy or plastic composition, e.g., nickel-titanium alloy sometimes called (“nitinol”), which has different properties at different temperatures. For example, the spokes may be assembled and the sleeve placed over them at very low temperatures, where they are very plastic and easy to assemble. After warming to room temperature or higher, the metal has a tendency to assume an expanded or other state that is particularly well suited for forming a basket or cage arrangement to hold the catheter tip against the heart wall or in close proximity to it. To remove or reposition the catheter, the sleeve would be advanced over the spokes to hold them in the retracted position.
The fixation device is not necessarily an expandable cage, but other fixation devices such as an expandable balloon, vacuum port(s) in the catheter wall or anchors may be used to affix the catheter at the desired location. A balloon attached to one side of the catheter (extending less than 360°, and preferably less than 180° around the catheter shaft) may be used for example to brace the catheter against the heart tissue to be ablated. Such a catheter would appear similar to that shown in
In addition to the features and functions described above, other aspects of the invention include having the distal end of the catheter more flexible than the main body of the catheter for improved steerability and/or less tissue trauma. Also, catheters may be used with or without guide wires. The pre-shaped guide. wires or pre-shaped catheters may have other shapes in addition to pig-tail or spiral.
It is known that ablation around the pulmonary vein using prior rf ablation techniques may result in stenosis, which is a closure, of the pulmonary vein. Stents have been used, sometimes unsuccessfully, to hold the vein open after an angioplasty procedure is performed to reopen the vein. It has been suggested by others that the Novoste™ Beta-Cath™ System may be used to treat or avoid restenosis of the pulmonary vein after such ablation by irradiating the inside of the pulmonary vein with ionizing radiation.
One or more of the apparatus described above could be used to-treat restenosis of the pulmonary vein by applying an appropriate dose of radiation to the site of the ablation. For example, the basket or cage fixing means may be used to position the radiation delivery catheter at the desired location within the pulmonary vein, with the catheter in close proximity to the area of ablation, to diminish the growth of scar tissue (a predominant factor in stenosis following damage to blood vessels by angioplasty, stents and the like). Or a pigtail or spiral shaped guide wire could be used with a radioactive source delivery catheter for achieving the same objective.
Although shown ablating a line around a pulmonary vein, the above method could be used to form a lesion line around more than one pulmonary vein simultaneously.
For purposes of illustration, and not limitation, the steering wire controller is generally illustrated as a rotating pulley or wheel 92 with opposed steering wire guides 94 through which the steering wire is slidably received. The steering wire has stop members 96 located for engagement by the guides when the wheel 92 is turned. With this arrangement, turning the wheel results in pulling one wire and releasing the other to bend the tip toward the pulled wire. Reversing the direction of the wheel reverses the direction of tip curvature.
Although this embodiment employs a single length of wire or cable to form both of the steering wires, it should be apparent that separate wires could be used without departing from the broader aspects of this invention. This steering wire construction also is not limited to a radiation source catheter, but may be used in any catheter that needs to navigate tortuous body passageways, such as cardiology catheters.
The catheter 98 shown in
As seen there, one steering wire includes a bend or curve-accommodating segment, generally at 116. Such a segment could be located in both wires, if so desired. The bend-accommodating segment 116 is formed of a plurality of undulations in the steering wire and is preferably in the form of a plurality of coils like a coil spring. This segment allows for greater curvature when tension is placed on the other steering wire. The curve-accommodating segment gives elongation to the wire for a tighter (smaller) radius of curvature. It is understood that when the steering wire 114 is pulled or tension applied, the curve accommodating segment is, in effect, pushing the other steering wire—the combination of tension and compression results in smaller radius of curvature.
The illustrated catheter 98 in
The bend feature could, of course, be used in a steering wire that does not have a bend-accommodating segment 116. However, by having both features in the same steering wire it is possible to cause the distal portion of the catheter to bend in two different directions simultaneously with a relatively small radius of curvatures in at least one of those. For example, by pulling on both steering wires, the engagement between the bend 118 and the plug 120 causes the distal end to bend in a direction opposite the bend. Pulling of steering wire 114 causes the more distal tip portion to bend in the direction that steering wire 114 is being pulled, and the bend accommodating segment 116 allows that bend to be of an even smaller radius than could otherwise be achieved. This could result, for example, in the distal end portion extending in a plurality of different directions For example, the distal end portion could have a generally L-shaped bend at bend 118 and a generally C-shaped curve at curve-accommodating segment 116, or it could have a generally S-shape. The curves could be in the same plane or in different planes, affording a variety of shapes to the surgeon for navigating through complex body lumens, or for positioning the catheter against or in proximity to the tissue to be treated.
The illustrated tubular U-shaped lumen connector 110 located in the distal tip of the catheter connects the source and return lumens in fluid communication. The lumen connector allows the fluid, which transports the radioactive source to the distal end portion, to return to the proximal end portion. It is preferably metallic or of rigid plastic construction and also serves to add strength and stability to the end of the catheter.
Additional features and advantages may be apparent to one skilled in the filed upon review of this description, and it is intended that the application include such obvious variations and changes that may be made without departing from the present invention.
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|3||International Preliminary Examinatin Report re application No. PCT/US02/30159, dated Sep. 27, 2004.|
|4||International Search Report re application No. PCT/US02/30159, dated Mar. 18, 2003.|
|International Classification||A61N5/10, A61N5/00, A61M25/00, A61M25/01, A61M36/04|
|Cooperative Classification||A61M2025/004, A61M2025/0034, A61M25/0147, A61B2017/003, A61B2018/00363, A61B2018/00577, A61N5/1002, A61B2018/00559|
|European Classification||A61M25/01C10K, A61N5/10B1|
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|Jun 11, 2015||FPAY||Fee payment|
Year of fee payment: 4
|Jun 11, 2015||SULP||Surcharge for late payment|